Hearing LossNCT05476328
Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients.
A study testing SPACE, OPAL-SPACE and ACE in people with Hearing Loss, run by Cochlear at 5 sites in 2 countries.
Trial summary
This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant. Subjects older than 5 years will be included. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- SPACE, OPAL-SPACE and ACE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 22 Jan 2020to 17 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding.
- Paediatrics: Older than 5 years and <18 years when entering the study. (Belgium only) or
- Adults: ≥18 years when entering the study (Belgium and Australia).
- Subject/legally designated representative is fluent speaker in the language used for assessments.
- Willing and able to provide written informed consent (for paediatric populations this criterion applies to the parent/ legally designated representative).
Who cannot join
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
- Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Belgium3 sites
AZ Sint-Jan Brugge-Oostende AV
Bruges, 8000
Cochlear Technology Centre Belgium
Mechelen, 2800
Sint-Augustinus Antwerpen
Wilrijk, 2610
Australia2 sites
HEARnet Clinical Studies
Carlton, Victoria, 3052
Cochlear Ltd. Melbourne
East Melbourne, 3002
About this study
Official title: A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Sound Processing in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation.
This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant.
Subjects older than 5 years will be included. Subjects will be screened and up to 120 eligible subjects will be recruited in the clinical investigation.
Read more
Subjects will attend scheduled study visits over a period up to 5 years in different sub-studies as described in the sub-study documentation.
A clinical setting can consist of therapeutic elements and evaluations. Subjects will be assessed with the commercially available Nucleus sound processor or via the xPC, NIC, etc. if required. Acute testing will be done where possible. Take home use will be applied when learning effects may play a significant role and to evaluate the acceptance of the new or improved sound coding algorithm or signal processing, in as many listening environments as possible. The subject might also be asked to complete questionnaires, to perform at-home tests etc. during this take home use and/or at the clinical visits. The time for a clinical visit will be limited to a maximum of 4 hours. The time in between clinical visits will vary with typical spacing of between 0 (acute) to 4 weeks.
The goals of this umbrella investigation are to measure hearing outcomes to assess performance and/or to achieve higher convenience for implant users and hearing care professionals. The outcomes of the study will guide Cochlear to select features for inclusion in future Nucleus cochlear implant systems and/or future models of care.
- Conditions
- Hearing Loss
- Being tested
- SPACE, OPAL-SPACE, ACE, Cochlear Device Interface (CDI) Tool
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPACEDevice
Also called Spread Precompensation Advanced Combination Encoder
SPACE (Spread Precompensation Advanced Combination Encoder) is a sound coding strategy that is intended to improve spectral resolution, and hence hypothesised to improve cochlear implant (CI) speech understanding in noise. It is an alternative to the ACE sound coding strategy. It has been implemented on the Nucleus 7 CP1000 sound processor for CIC4-based implants.
OPAL-SPACEDevice
OPAL-SPACE (combined OPAL and SPACE strategy) aims to preserve as many of the significant features encoded by both OPAL and SPACE strategies individually. Since SPACE codes spectral envelope information, while OPAL codes temporal periodicity information, it is reasonable to suggest that both coding techniques can be combined to improve perception additively.
ACEDevice
Also called Advanced Combination Encoder
Advanced Combination Encoder (ACE) is the commercially available, reference sound processing strategy.
Cochlear Device Interface (CDI) ToolDevice
For all strategies, programming will be performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Investigational software will be used to stream stimulation sequences to a commercially available N6 sound processor using the Cochlear NIC4.1 interface.
| Study group | Role | What they receive |
|---|---|---|
| All Participants | Other | Advanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. The evaluation order of sound strategies was counterbalanced. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Receives: Device: SPACE; Device: OPAL-SPACE; Device: ACE; Device: Cochlear Device Interface (CDI) Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monosyllabic Word in Quiet Scores.
Monosyllabic word in quiet scores (for conventional Advanced Combination Encoders and new sound coding strategy). Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome
Measured: One Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start22 Jan 2020
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Trium Clinical Consulting, Avania
- Responsible party
- Sponsor
- Investigators
- Komal Arora, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476328
- Sponsor's protocol ID
- AI5762
- Status last verified
- Feb 2025
- First submitted
- 27 Jun 2022
- Last updated
- 13 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility, Prospective, Repeated-measures Investigation to Investigate Innovations in Sound Processing in Adult and Paediatric Recipients Implanted With CE Approved Nucleus Cochlear Implants: an Umbrella Investigation.
- ClinicalTrials.gov ID
- NCT05476328
- Acronym / sponsor ID
- AI5762
- Conditions
- Hearing Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Collaborators
- Trium Clinical Consulting, Avania
- Study start
- 22 Jan 2020 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 27 Jul 2022 (actual)
- Results
- Posted 13 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility, prospective with sequential enrolment, multicenter, clinical investigation in adults and paediatrics with a CE approved Nucleus cochlear implant.
Subjects older than 5 years will be included. Subjects will be screened and up to 120 eligible subjects will be recruited in the clinical investigation.
Subjects will attend scheduled study visits over a period up to 5 years in different sub-studies as described in the sub-study documentation.
A clinical setting can consist of therapeutic elements and evaluations. Subjects will be assessed with the commercially available Nucleus sound processor or via the xPC, NIC, etc. if required. Acute testing will be done where possible. Take home use will be applied when learning effects may play a significant role and to evaluate the acceptance of the new or improved sound coding algorithm or signal processing, in as many listening environments as possible. The subject might also be asked to complete questionnaires, to perform at-home tests etc. during this take home use and/or at the clinical visits. The time for a clinical visit will be limited to a maximum of 4 hours. The time in between clinical visits will vary with typical spacing of between 0 (acute) to 4 weeks.
The goals of this umbrella investigation are to measure hearing outcomes to assess performance and/or to achieve higher convenience for implant users and hearing care professionals. The outcomes of the study will guide Cochlear to select features for inclusion in future Nucleus cochlear implant systems and/or future models of care.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All Participants | Other | Device: SPACE, Device: OPAL-SPACE, Device: ACE, Device: Cochlear Device Interface (CDI) ToolAdvanced Combination Encoder (ACE) sound processing strategy (reference strategy), Spread Precompensation Advanced Combination Encoder (SPACE), and Optimised Pitch and Language strategy-SPACE (OPAL-SPACE; combined OPAL and SPACE strategy) were evaluated in adult cochlear implant recipients. The evaluation order of sound strategies was counterbalanced. All strategies were programmed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Users of a CE approved Nucleus cochlear implant, resulting in open set speech understanding.
- Paediatrics: Older than 5 years and <18 years when entering the study. (Belgium only) or
- Adults: ≥18 years when entering the study (Belgium and Australia).
- Subject/legally designated representative is fluent speaker in the language used for assessments.
- Willing and able to provide written informed consent (for paediatric populations this criterion applies to the parent/ legally designated representative).
Key exclusion criteria (5 listed)
- Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
- Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
- Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
- Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation.
- Currently participating, or participated within the last 30 days, in another interventional clinical investigation/trial involving an investigational drug or device.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPACEAlso: Spread Precompensation Advanced Combination EncoderSPACE (Spread Precompensation Advanced Combination Encoder) is a sound coding strategy that is intended to improve spectral resolution, and hence hypothesised to improve cochlear implant (CI) speech understanding in noise. It is an alternative to the ACE sound coding strategy. It has been implemented on the Nucleus 7 CP1000 sound processor for CIC4-based implants. | Device | All Participants |
| OPAL-SPACEOPAL-SPACE (combined OPAL and SPACE strategy) aims to preserve as many of the significant features encoded by both OPAL and SPACE strategies individually. Since SPACE codes spectral envelope information, while OPAL codes temporal periodicity information, it is reasonable to suggest that both coding techniques can be combined to improve perception additively. | Device | All Participants |
| ACEAlso: Advanced Combination EncoderAdvanced Combination Encoder (ACE) is the commercially available, reference sound processing strategy. | Device | All Participants |
| Cochlear Device Interface (CDI) ToolFor all strategies, programming will be performed using a research version of Custom Sound and the investigational software: Cochlear Device Interface Tool (CDI Tool). Investigational software will be used to stream stimulation sequences to a commercially available N6 sound processor using the Cochlear NIC4.1 interface. | Device | All Participants |
Primary outcome
Monosyllabic Word in Quiet Scores.
Time frame: One Day
Monosyllabic word in quiet scores (for conventional Advanced Combination Encoders and new sound coding strategy). Resultant score is percentage of words repeated correctly. Possible scores ranges from 0% to 100% correctly repeated. Higher percentage score means better outcome
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Komal Arora study director
Cochlear
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPACE, OPAL-SPACE and ACE in people with Hearing Loss, run by Cochlear at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monosyllabic Word in Quiet Scores. (time frame: One Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.